Date: Fri, 02 Jun 1995 19:12:12 -0700 (PDT)
Reply-To: Conference "aidstreatment"
From: Tadd Tobias
Subject: AIDS Treatment News Issue #224, June 2, 1995
AIDS TREATMENT NEWS Issue #224, JUNE 2, 1995
phone 800/TREAT-1-2, or 415/255-0588
CONTENTS:
Diarrhea, and the Experimental Treatment Saccharomyces
boulardii
When Treatments Go Untried
Gallo Starts Major AIDS Research Institute in Baltimore
Lymphoma: New TAG Report
Chinese Medicine: Where Does It Work Best in HIV/AIDS?
***** Diarrhea, and the Experimental Treatment Saccharomyces
boulardii
by John S. James
Saccharomyces boulardii is a live yeast widely used in Europe
and elsewhere to treat diarrhea; millions of doses are sold
each year. Recently, with increasing interest in using it for
HIV-related diarrhea, this potential treatment has become one
of the top sellers at some AIDS buyers' clubs, including
Healing Alternatives in San Francisco, and the PWA Health
Group in New York.
A number of published clinical trials (almost all in HIV-
negative persons) have reported apparent usefulness in
preventing or treating diarrhea resulting from various
causes. No one knows how S. boulardii may work, however. It
does NOT seem to kill diarrhea-causing organisms directly;
instead, it may reduce inflammation in the gut, or increase
certain immune responses in the blood. (The latter theory
might explain how one study found S. boulardii may have been
modestly useful for treating acne, even though the yeast did
not leave the intestinal tract.)
HIV-Related Research
Little research has been done with S. boulardii in persons
with HIV. In 1990, French researchers reported on 30 patients
who had four to eight liters of watery stools per day for at
least three months. When they were given three grams per day
of S. boulardii, "fecal output decreased to less than one
liter per day after 48 hours of treatment, and eight days
after the onset of the drug, stools were fully formed."(1)
The following year, the same research team reported on
improvement in 17 patients with HIV and diarrhea; in 12 of
them, the cause of the diarrhea could not be diagnosed. The
average number of stools decreased from 9 to 2.1 per day in
15 days, and there was an average weight gain of 8 kg (17.7
lbs).(2) Neither of these reports were from controlled
trials, however.
In 1992 French researchers reported the results of a placebo-
controlled trial of S. boulardii, in 36 patients with AIDS-
related diarrhea which -- importantly -- was not responsive
to any attempt to treat any known cause of the diarrhea.(3)
On entry into the trial, their average age was 34.8 years,
and their average weight was 58.7 kg (130 lbs). Thirty five
of the 36 patients completed the study. At the end of the
trial, 10 of 18 patients who received S. boulardii were
diarrhea free, vs. only 1 of 17 who received the placebo -- a
difference which is highly statistically significant. Also,
the treatment group gained 2.0 kg (4.2 lbs), while the
placebo group lost 3.1 kg (6.85 lbs); this difference is also
statistically significant. The length of the trial was not
stated in the abstract. As far as we know, this is the only
completed controlled trial of S. boulardii in persons with
HIV.
The latest medical article anywhere on S. boulardii in HIV-
related diarrhea was published in 1993; it is a case report
of a successful treatment.(4) (Unfortunately, one major
computer database mis-translated the German title into
English as "Saccharomyces boulardii Therapy of HIV Associated
Failures," instead of "Saccharomyces boulardii Therapy of HIV
Associated Diarrhea," giving a completely wrong impression of
the article. But the MEDLINE database generally used in the
U.S. does have the correct translation of the title.)
Until recently, 26 persons with HIV were being studied in
controlled clinical trials in Seattle. During the first two
weeks, some were randomly assigned to receive a placebo. Then
everyone received the drug in decreasing doses, to help
define the safest and most effective maintenance dose.
Unfortunately, this trial was recently stopped -- for
business reasons, not because of any problem with the
treatment. (The sponsor decided to focus on another trial,
testing S. boulardii with antibiotics to prevent recurring
Clostridium difficile diarrhea; all the persons in that trial
must be HIV negative. That study may be finished by the end
of 1995; with luck, S. boulardii could be approved for
preventing C. difficile recurrences in about two years.)
S. boulardii appears to be quite safe; no serious adverse
effects have been found in any clinical trial. But one
theoretical danger is that this yeast could take advantage of
an immune deficiency and cause a systemic infection. Only two
cases of this have been reported, out of perhaps more than a
million people who have used the treatment since it was first
used for diarrhea in the 1950s. Both were probably HIV-
negative (neither had been tested, but neither was being
treated for anything HIV related); both previously had
serious intestinal problems which may have allowed the yeast
to leave the intestine and enter the bloodstream. Both cases
were successfully treated with amphotericin B, a powerful
antifungal.
Clinical Trials for Other Diseases
McFarland and Bernasconi(5) reviewed controlled trials
studying S. boulardii for treatment or prevention of diarrhea
due to various causes not related to HIV. All the results
reported below -- from studies they reviewed, and also from
more recent reports -- are from controlled trials, and are
statistically significant.
Three large trials studied S. boulardii for prevention of
antibiotic-associated diarrhea.(6,7,8) This condition can
occur as a side effect of certain antibiotics, which can kill
beneficial organisms in the gut and thus allow an overgrowth
of disease-causing organisms which are normally kept under
control. In all three of the trials, S. boulardii reduced the
incidence of diarrhea by at least 50 percent.
Two other controlled studies showed that S. boulardii
treatment caused about a two-fold or three-fold reduction in
diarrhea caused by feeding with a nasogastric tube.(9,10)
S. boulardii, used with certain antibiotics, has also been
studied for treating C. difficile, a serious intestinal
infection. After several positive case reports and
uncontrolled studies, a major placebo-controlled trial found
that S. boulardii plus antibiotics prevented recurrences of
C. difficile better than the antibiotics alone,(11) but this
could only be established for patients with a history of
recurrences; for those with their initial C. difficile
infection, the difference between the treatment and placebo
groups was not statistically significant. (This failure to
reach statistical significance does not mean that S.
boulardii failed to help in these cases, however; "because of
the small numbers of patients with initial CDD who failed,
there was only a 10% power of detecting a significant
difference; therefore, the result could be a type II
error."(11))
A study in a few patients with Crohn's disease also found
statistically significant benefit of S. boulardii in reducing
diarrhea.(12)
Researchers in Austria tested S. boulardii in 3,000 healthy
volunteers for prevention of travelers diarrhea. They gave a
small dose (250 mg per day), a moderate dose (1 gram per day)
or a placebo to persons about to travel to distant regions.
Those who received the treatment, especially the higher dose,
were significantly less likely to get diarrhea.(13)
Studies of S. boulardii for treating ordinary diarrhea in
children(14,15) have shown significant benefit. And in a
trial in adults,(16) the treated group did not have a
significant reduction in the number of stools, but it did
have a lower proportion of watery stools.
S. boulardii does not remain in the intestine after use is
stopped, but is eliminated from the body within several
days.(5)
Research findings differ on whether the yeast needs to be
alive when taken. Even dead yeast may cause some of the
effects which have been observed.
Note: A number of laboratory studies, animal studies, and
uncontrolled human trials, NOT involving HIV in any way, have
suggested that S. boulardii might be helpful in treating
specific kinds of diarrhea or other illnesses. In this
article, we have not reviewed or referenced those studies.
Instead, we have focused on all HIV studies, and on placebo-
controlled human trials for any condition.
Availability Today
At least two different S. boulardii products are available in
AIDS buyers' clubs today.
Laboratoires Biocodex, the French company now running
clinical trials of S. boulardii, markets a lyophilized
(freeze-dried) form of the yeast in Europe, South America,
and Africa, but not in the U.S. It is sold under different
brand names (Ultra-Levure(tm), Thiemann(tm), Perenterol(tm),
Floratil(tm)) in different countries. This product is
available from the PWA Health Group, the largest AIDS buyers'
club in New York (212/255-0520). The three-gram per day dose
used in trials for AIDS-related diarrhea is moderately
expensive; at the PWA Health Group, a four-day supply costs
$36. Biocodex has been selling S. boulardii since 1962.
A competing product sold by Jarrow Formulas is less
expensive; but whether the two products are equivalent is
controversial. The PWA Health Group only carries the Biocodex
version; while Healing Alternatives, the major AIDS buyers'
club in San Francisco, carries only the Jarrow brand; both
can ship the product anywhere within the U.S. Some health-
food stores also sell the Jarrow brand.
With the Biocodex product, each 250-mg capsule is formulated
to contain one billion live yeasts, when tested six months or
more after manufacture. According to Biocodex, their in-house
testing, which has not previously been published, has shown
that there can be as much as a two log (99 percent) drop in
the number of live yeasts in the month after manufacture.
According to Jarrow Rogovin, president of Jarrow Formulas,
this does not happen if the capsules are refrigerated.
With the Jarrow product, each 310-mg capsule is formulated to
contain at least 500 million live yeasts when manufactured;
it may contain more.
We believe that what is most important is to find out whether
or not S. boulardii may be helpful for you -- and that the
best way to do this is to try a test with the more
established Biocodex product, starting with three grams a day
(twelve 250-mg capsules) for at least a week, and preferably
for two weeks. (You might want to order additional supply, to
avoid running out if it does seem to work.) After this test,
if you decide to continue with S. boulardii, you might be
able to reduce the cost by reducing the dose, and/or
switching to the Jarrow product, to see if a less expensive
regimen works as well for you.
How S. boulardii Is Used
Because of the lack of scientific studies of S. boulardii for
persons with HIV, information on how to use this treatment is
highly anecdotal and imprecise, and sometimes contradictory.
According to at least one of the buyers' clubs, most people
using S. boulardii for HIV-related diarrhea start with 3
grams a day, and then work down to 1 gram a day if that is
sufficient to keep the diarrhea controlled. Most people
divide the dose into two or three portions, and take the
capsules with a glass of water after eating. (One
recommendation we have seen says two hours after meals;
another just says after eating.) Some people take a gram a
day or less "for gut regulation or stomach aches," even
without diarrhea. According to the PWA Health Group, there
are no known drug incompatibilities, although it has been
suggested that if fluconazole maintenance is being used, the
two treatments should not be taken at the same time, so that
the fluconazole will be less likely to kill the yeast.
How many people have used S. boulardii for HIV-related
diarrhea? No one knows; the PWA Health Group estimates that
maybe a few hundred people have tried it; and they have
received only one report of a suspected side effect, a rash.
Healing Alternatives was selling about 90 bottles a month
before a recent article in a gay newspaper in San Francisco
increased demand. It has only heard one anecdotal report that
the treatment did not work; all the other reports have been
positive, even with severe diarrhea. (Readers should keep in
mind, however, that negative results are usually the least
likely to be reported; the treatment is probably not working
as well as the existence of so few negative reports might
suggest.)
Perhaps the most serious safety concern with S. boulardii is
that appropriate medical care could be delayed, if people
treat themselves for diarrhea without first getting medical
attention so that the underlying cause of the problem can be
diagnosed and treated, when possible. People should remember
that the HIV-related medical studies cited above were done
with patients whose diarrhea either could not be diagnosed,
or could not be treated by standard means. In many cases,
standard medical care cannot help; this is why new treatments
are needed. But failure to use available therapy for a
treatable condition, such as CMV infection, could lead to
serious harm.
The Future
So far there has been very little study of use of S.
boulardii for treating AIDS-related diarrheas. We have heard
that a trial is being conducted in Germany; as far as we
know, this is the only study anywhere of S. boulardii in
persons with HIV. Biocodex may study it again for HIV
diarrhea sometime in the future, but probably not until the
development for C. difficile is complete. It would be very
difficult for anyone to conduct a legal, U.S. study of S.
boulardii independently of Biocodex, either using its
product, or any other; collaboration might be possible,
however.
Sally Cooper, executive director of the PWA Health Group in
New York, informally outlined some research directions she
would like to see, in a private communication to AIDS
TREATMENT NEWS on May 30, 1995:
"Things I'd like to see followed up: use in kids with HIV --
what a great thing to have a safe intervention for kids, who
have wicked diarrhea all the time, and there have been at
least two studies in non-HIV kids; amoebas (also a small
number of promising abstracts, much gentler than Flagyl and
even tinidazole, again safe for kids); various stomach
ailments; thrush and preventing the spread of thrush (as per
animal studies). 80% of the lymph is in the gut, so things
that work specifically in the gut, like S. boulardii and
ketotifen, seem especially interesting. Both are theorized
(and shown in people with ketotifen, but only in animals with
S. boulardii) to improve and maintain mucosal membrane health
in the gut. And people gain weight -- seems like more than
just stopping up the system. I suspect it might be an
excellent maintenance therapy for PWAs with low CD4 counts,
or anyone starting a major course of antibiotics, especially
clindamycin." [Note: tinidazole and ketotifen are drugs which
are approved in some countries but not in the U.S., and are
used by people with AIDS.]
The bad news is that none of this research is likely to start
for years; who would pay for it? But the good news is that a
great many people have used S. boulardii, and some people
have used it for AIDS-related diarrhea over the last several
years; from all we know at this time, the treatment appears
to be exceptionally safe.
The other good news is that if S. boulardii is going to work,
it works quickly, usually greatly reducing diarrhea within a
week or two. A short test should be enough to see if it is
going to work for you. If not, little has been lost. And if
the treatment does work, then the financial cost, and the
small, largely theoretical risk of serious side effects, may
be worth accepting.
References
1. Saint-Marc T, Sellem C, Rosello L, and Touraine JL.
Treatment of chronic diarrhea with Saccharomyces boulardii.
Sixth International Conference on AIDS, San Francisco, June
20-24, 1990 [abstract #Th.B.363].
2. Saint-Marc T, Rossello-Prats L, and Touraine JL.
Efficacite de Saccharomyces boulardii dans le traitement des
diarrhees du SIDA. ANNALES DE MEDECINE INTERNE. 1991; volume
142, number 1, pages 64-65.
3. Blehaut H, Saint-Marc T, and Touraine JL. Double blind
trial of Saccharomyces boulardii in AIDS related diarrhea.
Submitted to the Eighth International Conference on AIDS,
Amsterdam, 1992, but not published in the conference
abstracts.
4. Born P, Lersch C, Zimmerhackl B, and Classen M.
Saccharomyces-boulardii therapie HIV-assoziierter durchfalle.
DTSCH. MED. WOCHENSCHR. 1993; volume 118, number 20, page
765.
5. McFarland LV and Bernasconi P. Saccharomyces boulardii: A
Review of an Innovative Biotherapeutic Agent. MICROBIAL
ECOLOGY IN HEALTH AND DISEASE. 1993; volume 6, pages 157-171.
6. Adam J, Barret A, Barret-Bellet C, and others. Essais
cliniques controles en double insu de l'ultra-levure
lyophilisee. Etude multicentrique par 25 medecins de 388 cas.
GAZETTE MEDICALE DE FRANCE. 1977; volume 84, pages 2072-2078.
7. Surawicz CM, Elmer GW, Speelman P, McFarland LV, Chinn J,
and Van Belle G. Prevention of antibiotic-associated diarrhea
by Saccharomyces boulardii: a prospective study.
GASTROENTEROLOGY. 1989; volume 96, pages 981-988.
8. McFarland LV, Surawicz CM, Greenberg RN, and others.
Prevention of beta-lactam-associated diarrhea by
Saccharomyces boulardii compared with placebo. THE AMERICAN
JOURNAL OF GASTROENTEROLOGY. 1995; volume 90, number 3, pages
439-448.
9. Tempe JD, Steidel AL, Blehaut H, Hasselmann M, Lutun PH,
and Maurier F. Prevention par Saccharomyces boulardii des
diarrhees de l'alimentation enterale a debit continu. LA
SEMAINE DES HOPITAUX DE PARIS. 1983; volume 59, pages 1409-
1412.
10. Schlotterer M, Bernasconi P, Lebreton F, and Wassermann
D. Interet de Saccharomyces boulardii dans la tolerance
digestive de la nutrition enteral a debit continu chez le
brule. NUTRITION CLINIQUE ET METABOLISME. 1987; volume 1,
pages 31-34.
11. McFarland LV, Surawicz CM, Greenberg RN, and others. A
randomized placebo-controlled trial of Saccharomyces
boulardii in combination with standard antibiotics for
Clostridium difficile disease. JAMA. 1994; volume 271, number
24, pages 1913-1918.
12. Plein K, and Holtz J. Therapeutic effects of
Saccharomyces boulardii on mild residual symptoms in a stable
phase of Crohn's disease with special respect to chronic
diarrhea -- a pilot study. Z. GASTROENTEROL. (Germany). 1993;
volume 31, number 2, pages 129-134.
13. Kollaritsch H, Holst H, Grobara P, and Wiedermann G.
Prevention of traveler's diarrhea with Saccharomyces
boulardii. Results of a placebo controlled double-blind
study. [English translation of the title.] FORTSCHR MED.
1993; volume 111, number 9, pages 152-156.
14. Chapoy P. Traitement des diarrhees aigues infantiles:
essai controle de Saccharomyces boulardii. ANNALES DE
PEDIATRIE 1985; volume 32, pages 561-563.
15. Cetina-Sauri G and Basto GS. Evaluacion terapeutica de
Saccharomyces boulardii en ninos con diarrea aguda. TRIBUNA
MEDICA. 1989; volume 56, pages 111-115.
16. Hochter W, Chase D, and Hagenhoff G. Saccharomyces
boulardii bei akuter erwachsenendiarrhoe. MUNCHENER
MEDIZINISCHE WOCHENSCHRIFT. 1990; volume 132, pages 188-192.
***** When Treatments Go Untried
by Denny Smith
The HIV pandemic is fourteen years along, affecting at least
that many millions of lives, with no certain end in sight.
New treatments are winding their way through laboratory
studies and clinical trials, but not at a pace that reassures
people who now have AIDS. For many, it is a situation defined
by anxiety.
Yet long-time observers have seen some true progress in HIV
research and clinical care. Four antiretrovirals are
available in developed countries. Though certainly inadequate
in the long run, they can at the least delay HIV progression
for many people, especially when used in combinations. And
almost every opportunistic illness can be controlled to some
degree with one or more treatments. Moreover, significant
progress has been made in the treatment of wasting, and
dementia is finally receiving the sort of attention that
could make a difference in outcome.
But we are concerned that potential treatments often lie idle
on pharmacy shelves, that useful treatment strategies are
languishing on the printed page, and that for many people the
hard-won progress in research and care generally is being
squandered. This impression grows out of years of
conversations with readers of AIDS TREATMENT NEWS, with
activists and physician friends, and with people who care for
someone with HIV.
Why do potentially valuable treatments go untried? Lack of
availability is the simple answer for millions of people,
especially in developing countries. Where availability is not
the problem, however, lack of motivation often is. Following
are the most common problems, in our view, and some potential
remedies. Some of the problems are nearly solved simply by
being acknowledged.
* Insufficient information
An enormous percentage of treatment decisions seem to be made
with only a limited number of options on the table.
For example, one reader told us that his doctor had no
treatment for a KS lesion on his eyelid that had grown so
much that his vision was impaired. Other lesions had
responded well to radiation, but his doctor said that
radiation would be dangerous focused directly toward the eye.
However, we had heard that a small lead shield could be
placed between the eye and the lid during radiotherapy. He
brought that information to his doctor and was successfully
treated within a few weeks.
Only coincidence and timing brought that information from an
unrelated treatment setting to AIDS TREATMENT NEWS and
through the patient back to his doctor. How could the process
be more dependable?
When faced with an apparent treatment dead-end, the physician
and the patient should consider whether all options have been
uncovered. The first resort could be a literature search
which calls up all relevant journal abstracts for the last
several years. Next, community news sources should be
surveyed, because a lot of potential treatments are tried in
the community before they attract well-funded research
backing. At some point, a specialist with HIV experience
should be consulted. Our friend's doctor had effectively
treated KS before, but only a radiation oncologist would be
likely to know about seldom-used techniques like the lead
shield.
* Acceptance of the "terminal" prognosis
Many people, including some who should know better, continue
to regard HIV infection as a terminal condition, rather than
a chronic, life-threatening disease. The distinction is
important for shaping public policy. But there are also
scientific reasons for dumping the word "terminal."
(1) According to data from the San Francisco Clinic Study,
which has tracked long-term HIV infection in hundreds of gay
men, among people who have been infected for ten to 16 years,
6.9% continue to have CD4 counts above 500; another 8.7% have
counts below 500 but above 200. No one can dismiss the
possibility that many of them will fulfill their natural life
expectancy. (2) For people with declining CD4 counts, the
antiretroviral drugs now on the market can delay the
progression to opportunistic illnesses for months or years.
(3) New treatments for opportunistic illnesses can extend
lives well beyond the first symptoms of AIDS.
Beyond inaccuracy, the "terminal" label can itself be life-
threatening, since a choice of words implies a choice of
action. The word "terminal" fosters a sense of resignation
for both the patient and provider, such that when a health
crisis presents itself, neither party is motivated to pursue
more than the minimal, most conservative diagnostic work-up
and treatment. It is an approach that certainly simplifies
life but, almost as certainly, shortens it. One does not get
more than what one settles for.
* Disinterested health care providers
Too many people with HIV are finding themselves under the
care of physicians who are simply unenthused about HIV
medicine. Sometimes there is little choice in the matter for
the patient; for reasons of geography, or health-care
coverage, they cannot easily switch doctors. Nor is it a
choice of every physician to assume the responsibility of
managing an unpredictable, complex disease for which
treatment recommendations are constantly changing.
Yet that is the situation faced half-willingly by physicians
and patients who meet each other in one of two contexts:
health-maintenance organizations (HMOs) and teaching
institutions.
HMO subscribers are limited to seeing only physicians who
participate in that health plan. Within this limit,
fortunately, it is often possible to find a good,
collaborative "match."
But people who do not have private insurance in the U.S.
often get their care in teaching institutions, where they are
followed by young interns who rotate through various clinical
situations as part of an extended residency program. Such
teaching programs are an important vehicle for taking medical
students from school into the real world of patients. But
they are also a great money-saver for large institutions,
which would otherwise have to pay enormous salaries to more
experienced physicians.
The interns can be caring and attentive and are sometimes
more willing than older, established physicians to try
innovative treatment approaches. But they are just as often
exhausted and hurried and prone to inappropriate assessments.
It is a system that can only guarantee minimal HIV training
to a new doctor and minimal health care to their patients.
Moreover, many people who get their care in teaching
institutions come from trying or troubled social settings,
and they tend to delay health care until the need is acute.
And so, in many instances, individuals with the most urgent
personal concern are tracked into a health-care setting with
the least eager professional concern.
One solution would be to exempt interns and residents from
patient care that they truly are unprepared for. Another,
parallel, solution is the HIV-focused clinic, where the care
is largely provided by experienced physicians, with some
uncomplicated patients managed by residents genuinely
interested in HIV medicine.
HIV infection should not, in our opinion, be considered just
another responsibility of general internal medicine. It
presents too many complexities that cross over many medical
disciplines, including immunology, hematology, dermatology,
infectious disease, gastroenterology, oncology, psychiatry
and neurology. HIV medicine warrants a distinct setting of
expertise, where each patient receives individualized care.
* Hyper-cautious providers
There are other health care providers who are both informed
about HIV and interested in treating it, but who adhere to an
oppressively conservative clinical approach.
What may be a well-worn strategy in some disease models can
be ill-applied to HIV. Diabetes, hypertension, heart disease
or liver disease usually have well-understood causes and
prognoses. They may best be managed with behavioral changes
and cautious observation. But other health crises, like
cancer and HIV disease, are fundamentally different. Caution
and behavioral counseling may prevent them but will not treat
them. Exam room philosophies like "watchful waiting," "if it
ain't broke...," and "do no harm" can have a legitimate
place, but miss the mark in contexts where progress has been
achieved with innovative, aggressive intervention.
One example of excessive caution is the unwillingness to
prescribe drugs off-label. Off-label refers to the use of an
FDA-approved drug for a purpose that was not part of the
original treatment indication, or "labeling." All physicians
have the professional discretion to prescribe any drug off-
label, and many drugs have been found to be invaluable for
new uses, such as mexiletine for neuropathy. To adhere
arbitrarily to the original labeling can deprive patients of
the treatment they need. This is an ethical, not a
regulatory, problem.
Another example of misplaced caution is the avoidance of
anecdotal or empirical evidence of treatments. A number of
indispensable HIV therapies started out as anecdotal reports
from physicians and patients who pioneered new treatment
approaches out of necessity. In many HIV-related situations,
there is no established treatment or the established
treatment just does not work for everyone. Today's anecdotal
report may be tomorrow's treatment.
* The artificial polarity between "conventional" and
"alternative" treatments
The U.S. has a large and vital alternative health culture.
Depending on how the word 'alternative' is defined, this
culture may encompass holistic or naturopathic medicine,
Chinese medicine and acupuncture, nutritional
supplementation, homeopathy, herbal medicine, chiropractic,
and other forms of treatment.
Unfortunately, alternative therapies are not taken very
seriously by many traditional physicians; and allopathic, or
conventional, "Western" medicine is often posed in the
community as the "other," a mercenary devil, the problem for
which alternatives exist. There is on both sides a propensity
toward unreasonable exclusion of the other.
The most productive approach would probably integrate
everything that works, with an eye toward dropping the
distinctions of alternative vs. conventional. If a treatment
works when nothing else has, what about it is "alternative"?
This idea was well presented in the following excerpt from a
manifesto by the New York activist Jon Greenberg, who died of
AIDS in 1993.
"The AIDS community tends to fall into two separate camps
regarding alternative therapies. Some dismiss all alternative
treatments, regardless of evidence demonstrating efficacy,
and others defend all alternative treatments, regardless of
evidence demonstrating toxicity or lack of efficacy. The
reality of most alternative therapies probably lies somewhere
between these two extremes . . . The goal of alternative
treatment activists is to advocate for controlled clinical
trials of alternative treatments, so that approval and
acceptance can be gained for those treatments which are found
to be effective. Our goal is to make the term 'alternative'
obsolete."
* Over-eager concerns about expense
We have met physicians who hesitate to use a potentially
valuable treatment if they think it is very expensive or will
not be reimbursed by the insurer. This is partly a symptom of
the inefficient, commerce-driven system of healthcare in the
United States. Doctors are forced to spend inordinate amounts
of time worrying about money instead of medicine.
At least some of the concern, however, may be inflated. We
know of instances in which a treatment was avoided by
physicians who assumed the cost could not be covered by the
insurance company, when in fact the same treatment had been
covered by that insurer when prescribed with convincing
documentation by other physicians.
Furthermore, many pharmaceutical companies have assistance
programs for patients who are underinsured. No treatment
should be automatically considered out of reach.
* The culture of rumor consumers
Many people will not take the approved antiretrovirals-AZT,
ddI, ddC, and d4T-because they heard the drugs do not work,
or even that they are "poison." The truth, less dramatic but
widely accepted, is that these drugs can inhibit HIV
progression to some limited degree, and also can cause some
side effects. But ever since it became clear the drugs were
not the final answer, and that not everyone has the same
experience with each drug, a subculture of misinformation has
been simmering.
This subculture is characterized by inconsistency. Some
people who absolutely refuse to try AZT are inexplicably open
to the other nucleosides (some of which have potentially more
serious toxicities). Others will not use any nucleoside
analog whatsoever but are famous for tying up community
hotlines each time the words 'AIDS' and 'treatment' appear in
a television newscast.
No one should be faulted for having legitimate qualms about
drug toxicities, or a legitimate interest in new research
developments. But mainstream news sources rarely get a story
straight, and someone who will not consider a reasoned
treatment approach from their doctor is ill-prepared to
interpret a patchwork story from an evening newsmagazine.
The community-generated news media, where the stakes are more
personal than mercantile, can be a more dependable source of
HIV news, but can also display more subjectivity than
objectivity. Some community news sources have allowed very
irresponsible opinions to be set forth as newsworthy. These
include the discredited idea that HIV is harmless, the claims
that AZT is a prohibitively toxic drug with no redeeming
benefit, and the advice that everyone can or should manage
AIDS exclusively through non-medical therapies.
There is a disingenuous approach to medical news throughout
the larger culture that is fueled by a contemporary anti-
science trend in America and that has unfortunately found
some friends in HIV treatment circles. Mostly this trend just
obstructs a presentation of the news in its entirety. But at
its worst, anti-science thrives on promotions which tug
selectively at people's cynicism: HIV is the product of a
government plot and pharmaceutical drugs are an extension of
this plot, or AIDS is simply an imbalance of oxygen or energy
in the body, or the U.S. research establishment can't be
trusted but a clinic in Switzerland or Kenya or Mexico has a
cure. Promotions, or evasions, like these are not always
mistruths so much as manipulated bits of the larger truth.
Anti-science often shares company with the superstitions of
right-wing ideology, including creationism, anti-
environmentalism, and the demonization of homosexuals. All
anti-science ideology endangers the fight against AIDS in one
way or another. Not the least of these are the paranoias
keeping some people from medical therapies that could extend
the length and quality of their lives.
* * *
Running through all of these problems is the lack of a
widely-accepted, coherent treatment strategy for HIV. Piece-
meal management by conflicting agendas does not serve the
AIDS community well. The problems above should be solved with
long-term strategies that anticipate and not merely react to
crises, strategies that are generated together by people with
HIV and the health professions.
***** Gallo Starts Major AIDS Research Institute in Baltimore
by John S. James
Leading AIDS scientist Robert Gallo, M.D. is leaving
government service after 30 years at the U.S. National Cancer
Institute, to start the Institute of Human Virology, which
will be part of the University of Maryland system. The new
Institute will focus on AIDS, but will also do research in
other human viral diseases, and in cancer.
The Institute is being started with over $16 million in
funding from the state of Maryland, the University of
Maryland, the city of Baltimore, and other sources. It will
begin operations this fall with a staff of 50; Dr. Gallo
hopes it will eventually grow to have a staff of about 250
and an annual budget of $30 million.
Dr. Gallo told AIDS TREATMENT NEWS that the Institute will
focus on basic research, primarily to develop better
therapies. Specific areas include gene therapy, antisense,
looking for treatments which target cellular factors which do
not mutate as rapidly as the virus (e.g. hydroxyurea), and
hormonal control (e.g. HCG, the hormone found at high levels
in pregnant women which may help to control Kaposi's
sarcoma). Other research will involve manipulation of
cytokines to treat HIV. An immediate goal is to "hit the
ground running" with a focus on KS.
Dr. Gallo noted the calls for virology research centers near
rain forests, to watch for emerging viruses. He said we also
need centers elsewhere which are immediately ready to study
viruses which break through, as AIDS did.
Dr. Gallo will be program director for basic research. He
will share leadership with two other program directors,
William Blattner, M.D., in epidemiology, and Robert Redfield,
M.D. in clinical research. Dr. Gallo believes this is the
first AIDS research institute to combine basic research,
clinical research, and epidemiology -- which will allow, for
example, the development of a cohort of well-studied patients
who can volunteer for trials of new therapies which are
particularly appropriate for them. Gallo also hopes to start
a biotechnology company, to be called Virex, which will allow
new discoveries to move immediately into drug development,
without waiting until business executives elsewhere get
interested.
The Institute is also beginning collaborations with leading
private and government research centers in the U.S., in
Europe, and in Asia. It is setting up an ultra-modern
telecommunications system, with the help of one of the
founders of CSPAN.
Dr. Gallo praised Parris N. Glendening, Governor of Maryland,
whose brother died of AIDS last year. Governor Glendening,
who formerly taught at the University of Maryland, has been
personally involved in negotiations for the Institute for the
last six months.
Comment
Dr. Gallo has been one of the most productive AIDS
scientists. At the National Cancer Institute he was hampered
by lack of a clinical partner, problems with technology
transfer, government rules which are becoming increasingly
burdensome despite activists' work, and repeated
investigations resulting from years'-long demonization by the
CHICAGO TRIBUNE and by the office of Congressman John Dingell
(Democrat, Michigan). The new Institute should allow more
effective focus on the task at hand of finding better
treatments for AIDS.
***** Lymphoma: New TAG Report
The Treatment Action Group (TAG) has published a 64-page
booklet on the current status of AIDS-related lymphoma. THE
LYMPHOMA PROJECT REPORT: CURRENT ISSUES IN RESEARCH AND
TREATMENT OF AIDS-ASSOCIATED LYMPHOMA, by Michael Marco, with
an introduction by Lawrence D. Kaplan, M.D., is based on
interviews with dozens of experts.
Lymphoma, of which there are several kinds, is a cancer of
the lymphatic system which occurs in HIV-negative as well as
HIV-positive persons; it is much more common in persons with
immune deficiency (whether caused by HIV, by drugs to prevent
rejection of organ transplants, or by other causes) than in
the general population. Lymphoma occurs in about five to ten
percent of persons with HIV, often after AIDS has been
diagnosed (although it is the first AIDS-defining illness in
about three percent of persons with AIDS). While it can occur
at any CD4 (T-helper) count, the risk is greater when the
count is low. However, the length of time one is HIV infected
may be a more important risk factor than the degree of immune
suppression; for this reason, the number of cases of lymphoma
is increasing since people with HIV are now living longer
than before. Unlike Kaposi's sarcoma, which occurs mainly in
gay men, lymphoma occurs about equally in all HIV risk
groups; for unknown reasons, white men are at a slightly
higher risk than others.
Sometimes lymphoma is found in a single rapidly-swelling
lymph node; in other cases there is no specific sign, and the
disease is difficult to diagnose.
Lymphoma can be cured in many cases, with chemotherapy,
radiation, or other treatments. But it still remains a major
life-threatening condition, with many people living less than
a year after diagnosis.
The TAG booklet, first released May 1995 at the 31st Annual
Meeting of the American Society of Clinical Oncology, looks
at all aspects of AIDS-related lymphoma, including
conventional and experimental treatments. It includes 23
recommendations, mainly for improving future research. The
writing is fairly technical, about at a medical-student
reading level.
THE LYMPHOMA PROJECT REPORT is available for $10 from
Treatment Action Group, 200 East 10th Street #601, New York,
NY 10003. It is available free of charge to people living
with HIV disease who cannot afford to pay: call TAG at
212/873-9044.
***** Chinese Medicine: Where Does It Work Best in HIV/AIDS?
In San Francisco, where Chinese medical treatment has been
funded for three years by the Ryan White CARE Act, the
American College of Traditional Chinese Medicine has treated
over 300 symptomatic HIV-positive patients in long-term care.
A study of the medical records of these patients, and of
quarterly health surveys, has identified seven HIV-related
conditions which appear to be most responsive to Chinese
medicine.
These seven conditions are: weight loss; diarrhea/loose
stools; abdominal pain; nausea; headaches; enlarged lymph
nodes; and neuropathy.
Note: The American College of Traditional and Chinese
Medicine can be reached at 415/282-9603.
Reimbursement Issues
After many years of refusing to pay for "alternative" care
such as traditional Chinese medicine, the trend today is
toward coverage by insurers and other third-party payers. The
reason is that alternative care usually costs much less than
Western medicine, and companies can save money by paying for
it.
In San Francisco, acupuncture was covered under the health
plan for city employees for several years, but was
discontinued last year due to a budget shortage. It has now
been restored effective July 1. But the San Francisco plan
has only covered acupuncture; other parts of traditional
Chinese medicine, such as herbal treatment, have had to be
paid by the individual. There is now a movement to expand
coverage for San Francisco employees, and for others; San
Francisco supervisor Angela Alioto has been very supportive.
The state of California has licensed acupuncturists for many
years. (The law also allows medical doctors to practice
acupuncture, regardless of whether they have been licensed or
trained to do so.) California law requires health insurance
companies which have their home office in California, and
which are not HMOs or PPOs, to cover acupuncture treatment.
Many of these companies, however, have ignored the law and
refused to do so.
For information on how you can help to expand health-care
coverage for traditional Chinese medicine in San Francisco
and in California, call George Wedemeyer at 415/661-2080.
***** AIDS TREATMENT NEWS
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Internet: aidsnews@igc.apc.org
Editor and Publisher:
John S. James
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Richard Copeland
Thom Fontaine
Tadd Tobias
Statement of Purpose:
AIDS TREATMENT NEWS reports on experimental and
standard treatments, especially those available now. We
interview physicians, scientists, other health
professionals, and persons with AIDS or HIV; we also
collect information from meetings and conferences,
medical journals, and computer databases. Long-term
survivors have usually tried many different treatments,
and found combinations which work for them. AIDS
Treatment News does not recommend particular
therapies, but seeks to increase the options available.
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ISSN # 1052-4207
Copyright 1995 by John S. James. Permission granted for
noncommercial reproduction, provided that our address
and phone number are included if more than short
quotations are used.